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Breakthrough FDA Approval: Zegfrovy (Sunvozertinib) Targets Rare Lung Cancer
Administration granted accelerated approval to Zegfrovy ( sunvozertinib ) for adults with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations , following progression on platinum‑based chemotherapy. Clinical Trial Highlights Overall response rate (ORR): 46% (95% CI, 35–57%) as per the phase 1/2 WU‑KONG1B study involving 85 patients. Duration of response (DoR): Median 11.1 months (95% CI, 8.2–not reached). Manageable safety profile: Includes gastrointestinal effects, dermatologic and ocular toxicity, pneumonitis risks. Companion Diagnostic Innovation On July 7, 2025, FDA also approved the Oncomine™ Dx Express Test (Ion Torrent Genexus Dx) to rapidly detect EGFR exon 20 insertions, enabling timely precision oncology decisions. Global Context & Future Developments Sunvozertinib had previously received conditional approval in China (WU‑KONG6 study, ...
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